Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-05 @ 3:02 PM
Study NCT ID:
NCT03793218
Status:
WITHDRAWN
Last Update Posted:
2024-01-11
First Post:
2019-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alar Batten Graft vs Latera for Nasal Valve Collapse
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
A Comparison of Alar Batten Graft to the Latera Nasal Implant for the Treatment of Nasal Valve Collapse
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution before participants were enrolled.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nasal obstruction is a common complaint for the patient presenting to the Otolaryngologist and/or the Facial Plastic surgeon. There are numerous potential causes of nasal obstruction, with more easily addressed pathologies such as posterior septal deviation and inferior turbinate hypertrophy often being over-diagnosed. Nasal valve obstruction, particularly dynamic nasal sidewall collapse, is of significant interest to the rhinoplasty surgeon. Traditionally, collapse of the nasal sidewall has been addressed via structural cartilage grafting, with alar batten grafting being the most commonly used method to provide support to the weak nasal sidewall. Recently, an absorbable nasal implant, comprised of a polylactic acid copolymer, has been advocated for supporting the nasal sidewall and relieving nasal obstruction. There are several proposed advantages of the implant over traditional operative techniques, namely the ease of endonasal insertion, which can be performed in the outpatient clinic setting. Preliminary investigations demonstrate subjective improvement in nasal obstruction with use of the implant, however, there has been no direct comparison with traditional techniques utilizing cartilage grafting.
This study is being done at both UVa and in Oregon. This prospective study will randomize patients with nasal obstruction and documented dynamic nasal sidewall collapse into one of two groups undergoing treatment with either endonasal batten grafting or the absorbable Latera nasal valve implant. Preoperative and postoperative nasal obstruction will be assessed with a validated survey for nasal obstructive symptoms, the Nasal Obstruction Symptom Evaluation (NOSE) score. The mean preoperative and postoperative NOSE score between the groups will be compared at 1, 6, 12, and 24 months post-operatively to compare the efficacy of both techniques. Subjects will be blinded to the surgical intervention they receive.
This study is being done at both UVa and in Oregon. This prospective study will randomize patients with nasal obstruction and documented dynamic nasal sidewall collapse into one of two groups undergoing treatment with either endonasal batten grafting or the absorbable Latera nasal valve implant. Preoperative and postoperative nasal obstruction will be assessed with a validated survey for nasal obstructive symptoms, the Nasal Obstruction Symptom Evaluation (NOSE) score. The mean preoperative and postoperative NOSE score between the groups will be compared at 1, 6, 12, and 24 months post-operatively to compare the efficacy of both techniques. Subjects will be blinded to the surgical intervention they receive.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: